More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.
- From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs
- The Endless Possibilities Of Closed-Loop RNA
- Five Maxims For Outsourcing Success
- Meet Hearables, The Next Revolutionary Medical Devices
- Qualification Considerations For A “Factory-in-a-Box”
- The Biotech Path To An Outsourcing Eden
- Patenting Antibodies: The 4 Tactics To Use In 2021
The Endless Possibilities Of Closed-Loop RNA
The world of RNA now encompasses multiple types of RNA, and circular RNA is a particularly intriguing format.
Meet Hearables, The Next Revolutionary Medical Devices
Hearables, in-ear devices that use sensors to monitor health, are poised to become the next revolutionary technology. Jacob Skinner, CEO of U.K.-based wearable technology design and development consultants Thrive Wearables, discusses its possibilities.
Qualification Considerations For A “Factory-in-a-Box”
The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the "factory-in-a-box," which can be a game-changer for the industry.
Patenting Antibodies: The 4 Tactics To Use In 2021
With epitope claims less available post-Amgen v. Sanofi, this article examines four useful approaches that you and your antibody patent lawyer can implement in order to improve your chances of obtaining valid antibody claims with functional attributes.
RNA Cell Therapy: A New Class of Advanced Therapies
RNA cell therapy is a new class of advanced therapies now in clinical trials to treat an array of diseases in and beyond oncology.
What Do Artificial Intelligence And Continuous Validation Have In Common?
Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.
The Role Of The Contract Manufacturer Under The EU MDR & IVDR
As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.
Outlook: Biotech In 2021 & Beyond
Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.
PHARMA OUTSOURCING WHITE PAPERS
Continuous Flow Manufacturing Of Pharmaceutical Ingredients
Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.
Understand Your Process: A Key To CMO Risk Mitigation
Inadequate communication and knowledge transfer between the originator and the CMO creates risk. This paper covers methods to reduce risks when moving from the lab to a GMP manufacturing setting.
Developing TIL Therapies: Sample Collection And Processing
While it has been advanced over many years, the process of developing TIL therapies still suffers from certain challenges. This article attempts to lay bare some of these challenges and discuss how novel technological solutions can help overcome them.
Mechanistic Modeling Of Chromatography To Speed Up Process Development
Catch up on the current opportunities and challenges for using mechanistic modeling to simulate and predict chromatographic behavior and experiments in silico.
Making The Medicine Go Down: Specialized Delivery Technologies
In this article, Sandra Conway, Technical Lead at Pfizer CentreOne discusses some of the drug development technologies that provide a more specialized approach to oral dose delivery.
Using Software Systems To Drive A Successful CPV Program
An area of life sciences that has recently received significant attention around data, its integrity, and its management processes, is manufacturing. This article covers bio/pharma manufacturing process information management systems, with insights on how purpose-built systems incorporated into your continued process verification (CPV) program helps meet FDA requirements and protect your business.
COVID-19 AND YOUR SUPPLY CHAINS
The Latest Analysis And Advice From Outsourced Pharma
OUTSOURCED PHARMA CONTENT COLLECTIONS
Quality, Supply Chain Agility, Analytical Development: These are the subjects of three thought-provoking whitepapers on our biopharma industry, reviewed and analyzed for Outsourced Pharma readers by Chief Editor Louis Garguilo. Important in their own right, see how Garguilo pulls out the most salient points from the reports to help readers increase your understanding and efficacy of drug development and manufacturing outsourcing.More Content Collections
PRODUCTS & SERVICES
SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.